Executive Director, Data Management
Xencor
4 hours ago
Remote friendly (San Diego, CA)
United States
IT
Primary Responsibilities:
- Design and execute a scalable Clinical Data Management (CDM) strategy supporting an expanding portfolio, including programs approaching Phase 3
- Lead the CDM function: recruit, train, mentor, manage performance, and support growth of the CDM department
- Provide operational leadership for acquisition, integration, quality control, and delivery of clinical trial data
- Oversee vendor and technology strategy (evaluation, selection, contracting, and performance oversight) for CDM services from study start-up through database lock and final reporting
- Partner with Development functions (e.g., Clinical Operations, Clinical Development) to ensure CRF designs, data transfers, extracts, and other CDM activities support high-quality analyses and regulatory compliance
- Collaborate with Biostatistics and Statistical Programming to ensure data structures support efficient analysis, interim decisions, and regulatory submissions
- Lead risk-based data management strategies including centralized data review, dashboarding, and issue management workflows
- Serve as CDM functional expert for enterprise data standards and documentation; oversee development of data management documentation standards (e.g., Data Management Plans, eCRF completion guidelines, coding guidelines, Data Validation Specifications)
- Other duties as assigned
Qualifications:
- BS degree in a related field
- Minimum 18 years relevant experience
- At least 12 years clinical data management experience in pharma/biotech
- At least 6 years people/team management experience
- Prior clinical trial responsibility for full data management lifecycle
Required skills/knowledge:
- Knowledge of ICH, FDA, and GCP regulations and guidelines
- Thorough knowledge of MedDRA, WHODrug, CDASH, SDTM, and other CDISC foundational standards
- Understanding of data management technology, software languages, and computer systems
- Knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications
- Proficiency with multiple computer-based tools (e.g., Word, PowerPoint, Excel)
- Proven people leadership (manage, mentor, develop)
- Ability to collaborate cross-functionally via in-person, phone, and email
- Excellent verbal/written and interpersonal skills; strong relationship-building and conflict resolution
Education/Experience:
- BS degree in related field; 18+ years relevant experience; 12+ years CDM; 6+ years people management; full CDM lifecycle trial responsibility
Benefits:
- Competitive total rewards package including 401k match, healthcare coverage, and ESPP; annual bonus and equity grant
Application instructions:
- For more information, see https://xencor.com/careers/
- Design and execute a scalable Clinical Data Management (CDM) strategy supporting an expanding portfolio, including programs approaching Phase 3
- Lead the CDM function: recruit, train, mentor, manage performance, and support growth of the CDM department
- Provide operational leadership for acquisition, integration, quality control, and delivery of clinical trial data
- Oversee vendor and technology strategy (evaluation, selection, contracting, and performance oversight) for CDM services from study start-up through database lock and final reporting
- Partner with Development functions (e.g., Clinical Operations, Clinical Development) to ensure CRF designs, data transfers, extracts, and other CDM activities support high-quality analyses and regulatory compliance
- Collaborate with Biostatistics and Statistical Programming to ensure data structures support efficient analysis, interim decisions, and regulatory submissions
- Lead risk-based data management strategies including centralized data review, dashboarding, and issue management workflows
- Serve as CDM functional expert for enterprise data standards and documentation; oversee development of data management documentation standards (e.g., Data Management Plans, eCRF completion guidelines, coding guidelines, Data Validation Specifications)
- Other duties as assigned
Qualifications:
- BS degree in a related field
- Minimum 18 years relevant experience
- At least 12 years clinical data management experience in pharma/biotech
- At least 6 years people/team management experience
- Prior clinical trial responsibility for full data management lifecycle
Required skills/knowledge:
- Knowledge of ICH, FDA, and GCP regulations and guidelines
- Thorough knowledge of MedDRA, WHODrug, CDASH, SDTM, and other CDISC foundational standards
- Understanding of data management technology, software languages, and computer systems
- Knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications
- Proficiency with multiple computer-based tools (e.g., Word, PowerPoint, Excel)
- Proven people leadership (manage, mentor, develop)
- Ability to collaborate cross-functionally via in-person, phone, and email
- Excellent verbal/written and interpersonal skills; strong relationship-building and conflict resolution
Education/Experience:
- BS degree in related field; 18+ years relevant experience; 12+ years CDM; 6+ years people management; full CDM lifecycle trial responsibility
Benefits:
- Competitive total rewards package including 401k match, healthcare coverage, and ESPP; annual bonus and equity grant
Application instructions:
- For more information, see https://xencor.com/careers/